This Funding Opportunity Announcement (FOA) encourages research
grant applications focused on palliative care in geriatric populations. This
FOA emphasizes studies in a variety of settings including ambulatory care, hospitals
(and specific sites within hospitals including specialty wards, intensive
care units and emergency departments), assisted living facilities, and short-
and long-term care facilities; however, hospice and end-of-life settings are not
included within the scope of this FOA, as they are the subject of other NIH
programs. Rather, this FOA highlights research on palliative care in settings
and at time points earlier in geriatric patients' disease or disability
trajectories. Types of studies may include observational, quasi-experimental,
or interventional studies using primary data collection and/or secondary
analyses. Leveraging on-going cohorts, intervention studies, networks, data
and specimen repositories, and other existing resources and infrastructure
are encouraged.

Key Dates

Posted Date

September 19, 2013

Open Date (Earliest Submission Date)

January 5, 2014

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard
dates apply, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA)
is required and strictly enforced. Applicants must read and follow all
application instructions in the Application Guide as well as any
program-specific instructions noted in Section
IV. When the program-specific instructions deviate from those in the
Application Guide, follow the program-specific instructions. Applications that
do not comply with these instructions may be delayed or not accepted for review.

There are several options to submit your application to the agency through Grants.gov. You can use the ASSIST system to prepare, submit and track your application online. You can download an application package from Grants.gov, complete the forms offline, submit the completed forms to Grants.gov and track your application in eRA Commons. Or, you can use other institutional system-to-system solutions to prepare and submit your application to Grants.gov and track your application in eRA Commons. Learn more.

The American population is currently experiencing
unprecedented growth in numbers and in age. In 2000, there were approximately
282 million Americans, 12% of whom were age 65 or older. In 2025, the US
population is expected to grow to over 350 million individuals, of whom nearly
18% will be 65 years or older. By 2050, projections place the US population at
well over 400 million, 20% of whom will be age 65 years or older. Individuals
80 years and above, sometimes described as the oldest old, are the fastest
growing segment of the population and are expected to comprise over 30 million
Americans, or over 7% of the US population.

As the population ages, the prevalence of diseases and
conditions common in aging is also expected to increase. Dementia and cognitive
impairment, cardiovascular disease, cancer, and chronic lung disease will
likely continue to be the greatest sources of morbidity and mortality among
older adults, as well as the costliest conditions to healthcare systems;
however, the development of targeted interventions for specific chronic
diseases has far outpaced the development of approaches to preserve the quality
of life for patients living with such diseases.

The growing recognition that disease-specific management has
failed to address the total health needs of patients with serious illness
underscores the necessity to advance the science of palliative care.

Palliative care is defined here as an interdisciplinary person-centered
approach to treating patients with serious illnesses through relieving symptoms
and improving quality of life for patients and their families. Contrary to the
popular notion that palliative care and curative treatment are mutually
exclusive, palliative care can, in fact, be incorporated successfully into the
treatment regimen for life-threatening disease. In addition, palliative care is
sometimes used synonymously with end-of-life care; however, palliative care is
a broader concept involving care delivered at any stage of illness from
diagnosis through the terminal stages of disease.

Despite promising outcomes from a variety of palliative care
interventions, most studies have involved a focus on single diseases; however,
the majority of chronic diseases do not occur in isolation, particularly in
older adults. For example, individuals with 2 or more chronic conditions
comprise almost 2/3 of Medicare beneficiaries and account for 95% of Medicare
expenditures. Older adults with multiple chronic conditions pose a particular
challenge to providers and healthcare systems aiming to provide cost-effective
care with clinically desirable outcomes. Moreover, geriatric syndromes, such as
mobility disability, cognitive impairment, falls, and sensory impairment
involve multiple interacting risk factors and complex management approaches
that fit poorly within disease-specific treatment guidelines. In light of the
scientific progress in both geriatrics and palliative care in recent years, a
significant opportunity now exists to extend the science of palliative care to
the management of older adults with serious illnesses. Such an opportunity is a
natural extension of the science of both specialties, as geriatricians and
palliative care providers have traditionally focused on achieving many of the
same outcomes for their patients, such as improvement or preservation of
function, sustained quality of life, and special attention to patient and
caregiver treatment preferences.

In January, 2013, the Claude D. Pepper Older Americans
Independence Center at the Mount Sinai School of Medicine, the National
Palliative Care Research Center, and the National Institute on Aging
co-sponsored a meeting to address major knowledge gaps and research
opportunities in geriatric palliative care. A series of papers that emerged
from that meeting are slated for publication in consecutive issues of the Journal of Palliative Medicine from
July to November, 2013. An
introduction to this series can be found at http://online.liebertpub.com/doi/full/10.1089/jpm.2013.9499.

Scope

This Funding Opportunity Announcement (FOA) encourages
research grant applications focused on palliative care in geriatric
populations. This FOA emphasizes studies in a variety of settings including
ambulatory care, hospitals (and specific sites within hospitals including
specialty wards, intensive care units and emergency departments), assisted
living facilities, and short- and long-term care facilities; however, hospice
and end-of-life settings are not included within the scope of this FOA, as they
are the subject of other NIH programs. Rather, this FOA highlights research on
palliative care in settings and at time points earlier in geriatric patients'
disease or disability trajectories. Types of studies may include observational,
quasi-experimental, or interventional studies using primary data collection
and/or secondary analyses. Leveraging on-going cohorts, intervention studies,
networks, data and specimen repositories, and other existing resources and
infrastructure are encouraged. Topics of interest include, but are not limited
to:

Development and evaluation of management approaches that improve
quality of life, preserve or enhance function, or otherwise promote clinically
meaningful outcomes, both within care settings and across care transitions, in
seriously ill older adults.

Evaluation of treatment algorithms or clinical decision support
tools optimizing across multiple parameters including functional status,
patient and family preferences, clinical outcomes, and healthcare resources.

Evaluation of discontinuing treatments hypothesized to be
unnecessary in specific populations of older adults or in specific settings,
and barriers to such discontinuation among patients and caregivers.

Development of intervention strategies to relieve non-pain
symptoms in older patients, such as fatigue, dyspnea, nausea, constipation,
anorexia, sleep disturbance, delirium, and pruritis. (See Additional Guidance below for
further information about proposals focused on pain).

Development and evaluation of novel strategies to improve advance
care planning and/or articulation of treatment preferences among older adults.

Development and evaluation of innovative decision aids for
seriously ill older patients and/or their proxy decision-makers, such as
prognosis calculators and communication of prognosis.

Evaluation of new technologies for acquiring data about symptoms,
quality of life, treatment preferences, and other variables not routinely
captured as specific data elements in studies of older adults.

Addressing systemic challenges in conducting research studies of
palliative care in older adults, such as barriers to care, high rates of
disability and mortality, and compliance among patients, caregivers/family
members, and providers.

Analysis of the effects of coverage policies of Medicare and
other care funders on timely access to appropriate palliative care, and of the
effects of care coordination, payment bundling, or other organizational and
financing innovations on timely access to appropriate palliative care.

Development and evaluation of enhanced analytic methods for
quasi-experimental and observational studies of palliative care strategies in
older adults that, for example, address time-dependency, multimodal treatment,
or matching of control subjects.

NCCAM

NCCAM’s focus includes examination of complementary and
integrative practices that reduce symptom burden and optimize quality of life
across care settings and cultural contexts. Interventions of high program
priority for NCCAM include mind and body approaches such as mindfulness-based
stress reduction (MBSR), meditation, approaches that are delivered by
complementary health providers (e.g. acupuncture, chiropractic), and
movement-oriented complementary interventions (e.g. qi gong, tai chi, yoga). Examples
of specific research topics include, but are not limited to:

Assessing complementary and integrative palliative care
interventions on quality of life and functioning for varying severities and
trajectories of pain in chronic illness.

Developing and refining interventions for mitigation of common
symptoms associated with many chronic illnesses such as stress, nausea,
dyspnea, difficult movement, headaches, diarrhea, and weight loss.

Examination of the effectiveness of complementary and integrative
care delivery in diverse settings.

Assessing how chronically ill individuals from all racial/ethnic
and socio-economic status (SES) backgrounds communicate with their health care
providers or teams to make health care decisions regarding complementary
palliative care.

Observational approaches that identify components of integrative
or complementary palliative care that warrant evaluation in a future controlled
trial.

Identification of specific attributes that will define whether
chronically ill individuals will respond to a specific complementary
intervention for alleviating pain and/or anxiety.

Applications that focus on special populations (health disparities,
HIV/AIDS, military/veterans) are of specific interest. All applications
must be aligned to NCCAM’s mission, research priorities and strategic plan (http://nccam.nih.gov/). Applicants are
encouraged to establish research collaborations with NCCAM-funded investigators
as well as NCCAM’s Research Center Programs (http://nccam.nih.gov/research/centers).

Additional Guidance

Applicants are encouraged to enroll subjects who represent
accurately the broad range of age, gender, race, ethnicity, health, and
functional level in the geriatric population. Applicants are discouraged from
excluding subjects with cognitive impairment, frailty, or other age-related
complicating conditions without reasonable scientific justification.
Consideration of social factors is particularly encouraged in clinical studies,
as inattention to such issues as socioeconomic status, built environment
barriers, and attitudes and behaviors may likely threaten external validity.

Intervention studies may include traditional randomized
controlled designs or more innovative approaches, such as adaptive designs.
Low-cost pragmatic trials are particularly encouraged as they approximate more
closely real-world practice. Studies that evaluate the effects of an
intervention should define its specific parameters such that other
investigators or providers may accurately replicate the intervention. For
example, addition of expertise (e.g., academic detail, consultation, informal
caregiver) or diagnostic method (e.g., geriatric assessment) should also
include information about what specifically will be done and how subsequent
management decisions will be informed. For any intervention study, applicants are
encouraged to include patient-centered outcomes and, when possible,
cost-effectiveness analyses. Applicants are encouraged to consider using NIH
PROMIS measures for patient-reported outcomes.
A full list of available measures and support tools for incorporating these
measures into clinical studies are available at http://www.nihpromis.org. Investigators
may also refer to recent efforts on identifying appropriate outcome measures
for older adults with multiple chronic conditions, published in the Journal
of the American Geriatrics Society 2012; 60: 2333-2341.

Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.

eRA Commons - Applicants
must have an active DUNS number and SAM registration in order to complete the
eRA Commons registration. Organizations can register with the eRA Commons as
they are working through their SAM or Grants.gov registration. eRA Commons
requires organizations to identify at least one Signing Official (SO) and at
least one Program Director/Principal Investigator (PD/PI) account in order to
submit an application.

Grants.gov – Applicants
must have an active DUNS number and SAM registration in order to complete the
Grants.gov registration.

Program
Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should
work with their organizational officials to either create a new account or to
affiliate an existing account with the applicant organization’s eRA Commons
account. If the PD/PI is also the organizational Signing Official, they must
have two distinct eRA Commons accounts, one for each role. Obtaining an eRA
Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the
same as one already reviewed within the past thirty-seven months (as described
in the NIH
Grants Policy Statement), except for submission:

To an RFA of an application that was submitted previously as an
investigator-initiated application but not paid;

Of an investigator-initiated application that was originally
submitted to an RFA but not paid; or

Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Requesting an Application
Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed.

Required and Optional Components

The forms package associated with this FOA includes all
applicable components, required and optional. Please note that some components
marked optional in the application package are required for submission of
applications for this FOA. Follow all instructions in the SF424 (R&R)
Application Guide to ensure you complete all appropriate “optional” components.

Instructions for Application Submission

The following section supplements the instructions found in
the SF424 (R&R) Application Guide and should be used for preparing an
application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide
must be followed.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Appendix: Do not use the Appendix to circumvent page limits. Follow all
instructions for the Appendix as described in the SF424 (R&R) Application
Guide.

Planned Enrollment Report

When conducting clinical research, follow all instructions
for completing Planned Enrollment Reports as described in the SF424 (R&R)
Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions
for completing Cumulative Inclusion Enrollment Report
as described in the SF424 (R&R) Application Guide.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies
described in the NIH Grants
Policy Statement, and procedures for foreign institutions described
throughout the SF424 (R&R) Application Guide.

3. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications
before the due date to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies). Applicants must then complete the submission process by tracking the
status of the application in the eRA Commons, NIH’s electronic system for grants
administration. NIH and Grants.gov systems check the application against many
of the application instructions upon submission. Errors must be corrected and a
changed/corrected application must be submitted to Grants.gov on or before the application
due date. If a Changed/Corrected application is submitted after the deadline,
the application will be considered late.

Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:All PD(s)/PI(s) must include their eRA Commons ID in the
Credential fieldof the Senior/Key Person Profile Component of the
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH. See Section III of this FOA for information on
registration requirements.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management. Additional information may be
found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH. Applications that are
incomplete will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in
any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before
submitting the application and follow the Policy on the Acceptance for Review
of Unsolicited Applications that Request $500,000 or More in Direct Costs as
described in the SF424 (R&R) Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other
researchers well suited to the project? If Early Stage Investigators or New
Investigators, or in the early stages of independent careers, do they have
appropriate experience and training? If established, have they demonstrated an
ongoing record of accomplishments that have advanced their field(s)? If the project
is collaborative or multi-PD/PI, do the investigators have complementary and
integrated expertise; are their leadership approach, governance and
organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
managed?

If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Guidelines
for the Review of Human Subjects.

Inclusion of Women, Minorities, and
Children

When the proposed project involves clinical research,
the committee will evaluate the proposed plans for inclusion of minorities and
members of both genders, as well as the inclusion of children. For additional
information on review of the Inclusion section, please refer to the Guidelines
for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the
application as now presented, taking into consideration the responses to
comments from the previous scientific review group and changes made to the
project.

Renewals

For Renewals, the committee will consider the
progress made in the last funding period.

Revisions

For Revisions, the committee will consider the
appropriateness of the proposed expansion of the scope of the project. If the
Revision application relates to a specific line of investigation presented in
the original application that was not recommended for approval by the committee,
then the committee will consider whether the responses to comments from the
previous scientific review group are adequate and whether substantial changes
are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Applications from Foreign
Organizations

Reviewers will assess whether the project presents
special opportunities for furthering research programs through the use of
unusual talent, resources, populations, or environmental conditions that exist
in other countries and either are not readily available in the United States or
augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by the Center for
Scientific Review, in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.

Will receive a written critique.

Applications will be assigned on the basis of established
PHS referral guidelines to the appropriate NIH Institute or Center. Applications
will compete for available funds with all other recommended applications. Following
initial peer review, recommended applications will receive a second level of
review by the appropriate national Advisory Council or Board. The following
will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

When multiple years are involved, awardees will be required
to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR)
and financial statements as required in the NIH Grants
Policy Statement.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH Grants
Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting
requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and
405 of the Public Health Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.